Clinical Trial: Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatmen

Brief Summary: All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Detailed Summary: This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
Sponsor: Ulthera, Inc

Current Primary Outcome: Improvement in overall lifting and tightening of the skin [ Time Frame: 90 days post-treatment ]

As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall aesthetic improvement [ Time Frame: 365 days post-treatment ]

Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.


Original Secondary Outcome: Same as current

Information By: Ulthera, Inc

Dates:
Date Received: October 15, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 9, 2013
Last Verified: September 2013